Tissue capturing bone anchor

ABSTRACT

A bone anchor configured for use in anchoring an implanting portion to an anchor point. A bone anchor can be of particular use in anchoring soft tissue to a bone. A bone anchor can have a wire loop and a suture. The wire loop of the bone anchor can be configured to capture a suture and to pull a portion of the suture through a hole in the anchor body aiding in anchoring an item, such as tissue to a bone. Methods of using the bone anchor with a suture and a wire loop to attach an item are disclosed

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/774,675, filed Sep. 10, 2015, which claims priority to 371 NationalStage Entry Application Serial No. PCT/US2014/021774, filed Mar. 7,2014, which claims the benefit and priority of U.S. ProvisionalApplication Ser. No. 61/786,168, filed Mar. 14, 2013, which is herebyincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to medical devices and procedures. Moreparticularly, the present invention relates to devices and methods forsecuring soft tissue to a rigid material such as bone.

Description of the Related Art

There are several medical procedures where a surgeon needs to attachsoft tissue such as tendons or other soft connective tissue to bone. Onecommon example is a biceps tenodesis, a surgical procedure usuallyperformed for the treatment of biceps tendonitis of the shoulder. Abiceps tenodesis may be performed as an isolated procedure, but moreoften is part of a larger shoulder surgery such as a rotator cuffrepair.

The biceps tendon connects the biceps muscle to the bone. The tendonpasses from the muscle to the shoulder joint. Patients with bicepstendon problems may have a detachment of the biceps tendon from theradial tuberosity, for example, or they may have inflammation andirritation of the biceps tendon itself. Biceps tendon problems can alsooccur in conjunction with a rotator cuff tear.

A biceps tenodesis is a procedure that cuts the normal attachment of thebiceps tendon on the shoulder socket and reattaches the tendon to thebone of the humerus (arm bone). By performing a biceps tenodesis, thepressure of the biceps attachment is taken off the cartilage rim of theshoulder socket (the labrum), and a portion of the biceps tendon can besurgically removed. Essentially a biceps tenodesis moves the attachmentof the biceps tendon to a position that is out of the way of theshoulder joint.

To perform a biceps tenodesis repair, typically a surgical procedure isused and requires the multiple steps of externalizing the tendon, whipstitching it, threading suture through a tenodesis screw, drilling thenecessary bone hole and anchor insertion via screwing it in. This is adifficult procedure arthroscopically. Systems recently brought to marketstill require multiple steps and tools

SUMMARY OF THE INVENTION

Disclosed herein are various embodiments of a bone anchor that mayaddress the aforementioned needs. A bone anchor includes, for example,an expandable anchor body, an expander, and a retractable suturegrabber, where the expander comprises at least one expansion portion anda first opening in the distal end of the expander, and the retractablesuture grabber extends through the first opening. In some embodiments,the expander is displaceable between a first position relative to theanchor body and a second position relative to the anchor body, whereinthe expansion portion is configured to expand the anchor body when theexpander is in the second position.

In some embodiments, a bone anchor includes, for example, a retractablesuture grabber comprising a wire loop. In other embodiments two limbs ofthe wire loop extend through the expander and out of a proximal end ofthe expander.

Other embodiments of a bone anchor include, for example, an expanderwith a first opening and a second opening in the distal end of theexpander, where a suture extends through the second opening. In furtherembodiments, the suture also extends through the expander and out theproximal end of the expander. In some embodiments of a bone anchor, thesuture extends through the first opening of the expander. In furtherembodiments, the suture further extends through the expander and out theproximal end of the expander. In some embodiments, at least one openingis aligned along an axis of the expander. In some embodiments, at leastone opening is offset from an axis of the expander.

Some embodiments relate to an anchor/inserter assembly. Thisanchor/inserter assembly includes, for example, a bone anchor accordingto all of the disclosed embodiments and an insertion tool coupled to thedisclosed bone anchor. Some embodiment of the anchor/tissue assemblyinclude a retractable suture grabber comprising a wire loop and twolimbs of the wire loop extending through the expander, out of a proximalend of the expander, and through an axial passage in the insertion tool.Some embodiments of the anchor/tissue assembly include an expandercomprising a second opening in the distal end of the expander and asuture extending through the second opening, where a first limb of thesuture extends through the expander, out of a proximal end of theexpander, and through an axial passage in the insertion tool. A furtherembodiment includes a second limb of the suture extending along a sideof the insertion tool. Still a further embodiment includes the secondlimb of the suture being secured to the inserter handle.

Some embodiments relate to a method of attaching soft tissue to a boneanchor comprising inserting the bone anchor according to all of thedisclosed embodiments into a patient through a first arthroscopic port,pulling the suture grabber out of the patient through a secondarthroscopic port, passing a suture around soft tissue, pulling at leasta first limb of the suture out of the patient through the secondarthroscopic port, engaging the suture with the suture grabber, andretracting the suture grabber through the first opening in the distalend of the expander, thereby pulling the first limb of the suturethrough the first opening. In some embodiments of the method, the suturegrabber comprises a wire loop and engaging the suture with the suturegrabber by passing the suture through the wire loop. Further embodimentscan include inserting the anchor into the bone after retracting thesuture grabber. In some other embodiments, the method includes a secondlimb of the suture extending through either the first opening or thesecond opening in the distal end of the expander prior to insertion ofthe bone anchor. In still other embodiments, the method includesinserting the first limb of the suture through the second arthroscopicport prior to passing it around the soft tissue. In further embodiments,the method comprises the suture grabber being engaged by the first limband the second limb of the suture and both the first and second limbs ofthe suture can be pulled through the first opening when the suturegrabber is retracted. Another embodiment of the method of attaching softtissue comprises making a hole in bone. In some embodiments the hole ismade with a drill and the bone can be cleared of any soft tissue in theregion of the hole.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of one embodiment of a bone anchor inan undeployed or unexpanded state.

FIG. 2 depicts a perspective view of one embodiment of a bone anchor ina deployed or expanded state.

FIG. 3 depicts a cut-away view of one embodiment of a bone anchor in anundeployed or unexpanded state.

FIG. 4 depicts a perspective view of one embodiment of an expander.

FIG. 5 depicts a perspective view of one embodiment of a single pieceexpander.

FIG. 5A depicts a cut-away view of one embodiment of a single pieceexpander deploying a tined dual expansion anchor.

FIG. 6 depicts a perspective view of one embodiment of a two pieceexpander.

FIG. 6A depicts a cut-away view of one embodiment of a two pieceexpander deploying a bone anchor.

FIG. 7 depicts an exploded perspective view of one embodiment of aninserter tool.

FIG. 7A depicts an exploded perspective view of one embodiment of aninserter tool configured for use with a two piece expander.

FIG. 8 is a perspective view of one embodiment of an inner rod.

FIG. 9 is a perspective view of one embodiment of an outer rod.

FIG. 9A is a perspective view of one embodiment of an outer rodconfigured for use with a two piece expander.

FIG. 10A is a side view of one embodiment of a portion of a handle body.

FIG. 10B is a perspective view of one embodiment of a portion of ahandle body.

FIG. 11 is a perspective view of one embodiment of a threaded actuatorshaft.

FIG. 12 is a perspective view of one embodiment of a deployment knob.

FIG. 13A depicts a side view of one embodiment of an inserter with anattached anchor, a wire loop, and a suture.

FIG. 14 depicts an exploded view of one embodiment of an inserter andanchor.

FIG. 15 depicts a bicipital groove and surrounding bone of the shoulderand biceps.

FIG. 16 depicts a bicipital groove and surrounding bone of the shoulderand biceps.

FIGS. 17A to 17E depict a method of using one embodiment of an anchor tosecure soft tissue to a bone anchor.

FIGS. 18A to 18E depict a method of using one embodiment of an anchor tosecure soft tissue to a bone anchor.

FIGS. 19A to 19E depict a method of using one embodiment of an anchor tosecure soft tissue to a bone anchor.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components, unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized, and other changes may be made,without departing from the spirit or scope of the subject matterpresented here. It will be readily understood that the aspects of thepresent disclosure, as generally described herein, and illustrated inthe Figures, can be arranged, substituted, combined, and designed in awide variety of different configurations, all of which are explicitlycontemplated and make part of this disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the disclosure.It will be understood by those within the art that if a specific numberof an element is intended, such intent will be explicitly recited in theclaim, and in the absence of such recitation, no such intent is present.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. As used herein, the term “and/or” includes any andall combinations of one or more of the associated listed items. It willbe further understood that the terms “comprises,” “comprising,”“includes,” and “including,” when used in this specification, specifythe presence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof. Expressions such as “at least oneof,” when preceding a list of elements, modify the entire list ofelements and do not modify the individual elements of the list.

Some embodiments disclosed herein relate generally to anchors for use inanchoring tissue or objects in a body. More specifically, someembodiments disclosed herein relate generally to anchors for use inanchoring soft tissue to bone in a body. Some embodiments disclosedherein relate generally to anchors for use in anchoring sutures to abone in a body. Also some elements relate to individual components andsubcomponents of the systems described herein, as well as methods ofmaking and using the same. Some embodiments additionally relate to kitsand components used in connection with the anchor. Although thefollowing embodiments refer to the use of an anchor in anchoring tissue,a person of skill in the art will recognize that an anchor can be usedto anchor any range of items within a body.

An exemplary bone anchor can include features configured for retentionof the desired tissue and features configured for affixing the anchor tothe desired anchor point. FIG. 1 depicts a perspective view of oneembodiment of an unexpanded dual expansion bone anchor 400 comprising ananchor body 410 and an expander 480. The anchor has a distal end 402 anda proximal end 404.

The anchor body 410 has a first end 412 and a second end 414. In someembodiments, the first end 412 of the anchor body 410 is configured forplacement into a hole in a bone. In some embodiments, the anchor 400 isplaced in the hole in the bone so that the second end 414 is in closerproximity to the entrance hole into the bone than the first end 412. Theanchor 400 depicted in FIG. 4 has a radius at the first end 412 of r4and a radius at the second end 414 of r5. In some embodiments r4 and r5are the same. In some embodiments, r4 and r5 are different.

Anchor 400 can be inserted into an anchor point with an insertion tool.In some embodiments, the second end 414 of the anchor body 410 isconfigured for interaction with a portion of the insertion tool tothereby allow placement of the anchor 400 at the anchor point. In someembodiments, the second end 414 of the anchor body 410 can be configuredto abut portions of the insertion tool. The abutting interaction betweenthe anchor body 410 and the insertion tool can facilitate a transfer offorces between the insertion tool and the anchor body 414, whichtransfer of forces can facilitate anchor insertion and/or result indeployment or expansion of the anchor 400.

The anchor body 410 depicted in FIG. 1 has an axial bore 416. The axialbore 416 can extend partially or entirely through the anchor body 410.In some embodiments, the axial bore 416 can be a first axial borepartially extending along the length of the anchor body 410 and a secondaxial bore partially extending along the length of the anchor body 410.The axial bore 416 depicted in FIG. 1 extends the entire length of theanchor body 410.

The axial bore 416 can be sized and dimensioned to receive the expander480. The expander 480 depicted in FIG. 4 is partially disposed withinthe axial bore 416 of the anchor body 410.

The anchor body 410 depicted in FIG. 1 has plurality of first tines 418extending from a position proximal to the second end 414 of the anchorbody 410 to the first end 412 of the anchor body 410. Each of the firsttines 418 is internally defined by the axial bore 416 and radiallydefined by a plurality of first expansion slots 420. An anchor body caninclude any desired number of first tines 418 and first expansion slots420, including 10 or less, 5 or less, 4 or less, or two first tines 418and first expansion slots 420. The anchor body 410 depicted in FIG. 1has four first tines 418 and four first expansion slots 420.

The first tines 418 and first expansion slots 420 can be positioned atany desired radial position around the anchor body 410. In someembodiments, the first tines 418 and first expansion slots 420 can bepositioned at regular intervals around the anchor body 410. In someembodiments, the first tines 418 and first expansion slots 420 can beirregularly positioned around the anchor body 410. FIG. 1 depicts anembodiment of an anchor body 410 in which the first tines 418 and firstexpansion slots 420 are equiangularly positioned around the anchor body410.

Different embodiments of an anchor body 410 can additionally includefirst tines 418 and first expansion slots 420 of different lengths. Insome embodiments, the first tines 418 and first expansion slots 420 ofan anchor body 410 can have equal lengths. In some embodiments the firsttines 418 and first expansion slots 420 may have different lengths. Insome embodiments, the first tines 418 and first expansion slots 420 canbe configured to have different lengths in that some of the first tines418 may extend further from the second end 414 of the anchor body 410toward the first end 412 of the anchor body 410 than other of the firsttines 418. In some embodiments, the first tines 418 and first expansionslots 420 can have different lengths in that some of the first expansionslots 420 can extend further from the first end 412 of the anchor body410 toward the second end 414 of the anchor body 410 than others of thefirst expansion slots 420. FIG. 1 depicts an embodiment of an anchorbody 410 in which the first tines 418 and first expansion slots 420 haveequal lengths.

The anchor body 410 depicted in FIG. 1 has a plurality of second tines422 extending from a position proximal to the first end 412 of theanchor body 410 toward the second end 414 of the anchor body 410. Eachof the second tines 422 is internally defined by the axial bore 416 andradially defined by a plurality of second expansion slots 424. An anchorbody can include any desired number of second tines 422 and secondexpansion slots 424, including 10 or less, 5 or less, 4 or less, or twosecond tines 422 and second expansion slots 424. The anchor body 410depicted in FIG. 1 has four second tines 422 and four second expansionslots 424.

The second tines 422 and second expansion slots 424 can be positioned atany desired radial position around the anchor body 410. In someembodiments, the second tines 422 and second expansion slots 424 can bepositioned at regular intervals around the anchor body 410. In someembodiments, the second tines 422 and second expansion slots 424 can beirregularly positioned around the anchor body 410. FIG. 1 depicts anembodiment of an anchor body 410 in which the second tines 422 andsecond expansion slots 424 are equiangularly positioned around theanchor body 410.

Different embodiments of an anchor body 410 can additionally includesecond tines 422 and second expansion slots 424 of different lengths. Insome embodiments, the second tines 422 and second expansion slots 424 ofan anchor body 410 can have equal lengths. In some embodiments thesecond tines 422 and second expansion slots 424 may have differentlengths. In some embodiments, the second tines 422 and second expansionslots 424 can be configured to have different lengths in that some ofthe second tines 422 may extend further from the first end 414 of theanchor body 410 toward the second end 414 of the anchor body 410 thanother of the second tines 422. In some embodiments, the second tines 422and second expansion slots 424 can have different lengths in that someof the second expansion slots 424 can extend further from the second end414 of the anchor body 410 toward the first end 412 of the anchor body410 than others of the second expansion slots 424. FIG. 1 depicts anembodiment of an anchor body 410 in which the second tines 422 andsecond expansion slots 424 have equal lengths.

Some embodiments of an anchor body 410 can have a first set of tines 418and a second set of tines 422 of equal length. Some embodiments of ananchor body 410 can have a first set of tines 418 and a second set oftines 422 of different lengths. FIG. 1 depicts one embodiment of ananchor body 410 in which the first set of tines 418 is longer than thesecond set of tines 422.

Some embodiments of an anchor body 410 can have first expansion slots420 and second expansion slots 424 of equal length. Some embodiments ofan anchor body 410 can have first expansion slots 420 and secondexpansion slots 424 of different lengths. FIG. 1 depicts one embodimentof an anchor body 410 in which the first expansion slots 420 are longerthan the second expansion slots 424.

The first tines 418 and first expansion slots 420 and the second tines422 and second expansion slots 424 allow the expansion of the anchorbody 410 when the expander 480 is moved longitudinally in a directionfrom the first end 412 towards the second end 414 of the anchor body.When the anchor 400 is placed within a hole in a bone, the longitudinaldisplacement of the expander 480 towards the second end 414 of theanchor body 410 results in the radial expansion of the anchor body 410,and specifically results in the radial expansion of the first tines 418and first expansion slots 420 located at the first end 412 of the anchorbody and of the second tines 422 and second expansion slots 424 locatedat the second end 414 of the anchor body 410. In some embodiments, theanchor body 410 can be sized and dimensioned relative to the hole inwhich the anchor 100 is placed, so that the radial expansion of theanchor body resulting from the longitudinal displacement of the expander480 towards the second end 414 causes the first tines 418 and the secondtines 422 to engage with bone surrounding the hole in which the anchor400 is positioned. In some embodiments, the engagement of the bone bythe first tines 418 and the second tines 422 can be facilitated by teeth428 located on some or all of the first tines 418 and/or the secondtines 422. FIG. 1 depicts one embodiment of an anchor body 410 in whichteeth 428 are located on all of the first tines 418 and the second tines422. In some embodiments, the teeth (or ridges) 428 are designed toprevent the anchor 400 from displacing out of the bone. In someembodiments, the teeth 428 are designed to stabilize the anchor 400 inthe bone. In some embodiments, the teeth 428 are designed to hold theanchored tissue in proximity to the bone. In some embodiments, the teeth428 are designed to perform a combination of these and other functions.

In some embodiments, the teeth 428 may penetrate the bone, the teeth 428may partially penetrate the bone, the teeth 428 may form depressions inthe bone, or the teeth 428 may deform to fit to the bone.

In some embodiments, all of the teeth 428 on the anchor body 410 arcsimilarly sized and dimensioned. An anchor body 410 may also have two ormore types of teeth 428. Specifically, an anchor body 410 may have afirst set of teeth located proximate to the first end 412 of the anchorbody 410 on some or all of the first tines 418, and a second set ofteeth located proximate to the second end 414 of the anchor body 410 onsome or all of the second tines 422.

FIG. 2 depicts a perspective view of one embodiment of the dualexpansion anchor 400 comprising an anchor body 410 and an expander 480.The body 410 of the anchor 400 depicted in FIG. 2 has a first end 412, asecond end 414, an axial bore 416, first tines 418, first expansionslots 420, second tines 422, second expansion slots 424, and teeth 428.As depicted in FIG. 2, the expander 480 is completely positioned withinthe axial bore 416 of the anchor body 410. With the expander 480positioned completely within the axial bore 416 of the anchor body 410,the first end 412 of the anchor body 410 has a new radius r6 and thesecond end 414 of the anchor body 410 has a new radius r7. The expansionof the anchor body 410 caused by the new positioning of the expander 480results in radius r6 at the first end 412 of the anchor body 410 beinglarger than radius r4 at the first end 412 of the anchor body 410 asdepicted in FIG. 1, and in radius r7 at the second end 414 of the anchorbody 410 being larger than radius r5 at the second end 414 of the anchorbody 410 as depicted in FIG. 1. In some embodiments r6 and r7 are thesame. In some embodiments r6 and r7 are different. Additionally, whileFIGS. 1 and 2 depict an anchor 400 defined respectively by two radii r4,r5 or r6, r7, a person of skill in the art will recognize that aplurality of constant or non-constant radii can define some embodimentsof an anchor 400. Thus, an expanded anchor 400 may have uniform ornon-uniform radial expansion between a first end 412 and a second end414.

FIG. 3 depicts a perspective cut-away view of the same embodiment of thedual expansion anchor 400 comprising an anchor body 410 configured foruse with an expander (not shown). The body 410 of the anchor 400depicted in FIG. 3 has a first end 412, a second end 414, an axial bore416, first tines 418 and first expansion slots 420, second tines 422 andsecond expansion slots 424. An axial bore 416 has a longitudinal axis430 and can comprise a variety of shapes and sizes. In some embodiments,an axial bore may have a single shape and constant diameter throughoutthe length of the anchor body 410. In some embodiments, and as depictedin FIG. 3, the shape and size of the axial bore 416 may vary along thelength of the anchor body 410. A person of skill in the art willrecognize that variations in the shape and size of the axial bore 416can be used in connection with variations in the size and shape of theexpander (not shown) to achieve desired expansion of the anchor body410, to achieve desired placement of the expander (not shown) within theanchor body 410, and to facilitate and/or prevent certain movements ofthe expander (not shown) within the anchor body 410.

As depicted in FIG. 3, an axial bore 416 can comprise portions that arcparallel to the longitudinal axis 430 of the axial bore 416,perpendicular to the longitudinal axis 430 of the axial bore 416, orangled relative to the longitudinal axis 430 of the axial bore 416. Theaxial bore 416 can comprise a first sloped portion 432. The first slopedportion 432 can be located proximate to the first end 412 of the anchorbody 410, or as depicted in FIG. 3, separated from the first end 412 ofthe anchor body 410 by a parallel portion 438, parallel to thelongitudinal axis 430 of the axial bore 416. The first sloped portion432 can be configured to provide a cam surface for the expander (notshown) to facilitate movement of the expander (not shown) into the axialbore 416 and to thereby facilitate expansion of the radius of the firstend 412 of the anchor body 410 from radius r4 to radius r6.

The axial bore 416 can include a first stop 434. As depicted in FIG. 3,a first stop 434 is a wall non-parallel to the longitudinal axis 430 ofthe anchor body 410. As depicted in FIG. 3, the first stop 434 can beconfigured to provide an engageable surface to interact with portions ofthe expander (not shown) and thereby prevent the expander (not shown)from retracting once the expander (not shown) has advanced past adesignated point. Advantageously, prevention of the retraction of theexpander (not shown) enables the permanent placement of an anchor 400 inbone.

A first stop can be located a desired distance from the first end 412 soas to achieve a desired degree of spreading of the first end 412 of theanchor body 410. In some embodiments, the first stop 434 can be locatedso that the first end 412 of the anchor body 410 achieves an expandedradius of approximately 40 millimeters, 20 millimeters, 10 millimeters,5 millimeters, 2 millimeters, 1 millimeter, or any other desireddiameter.

The axial bore 416 can comprise a second sloped portion 436. As depictedin FIG. 3, the second sloped portion 436 can be located proximate to thesecond end 414 of the anchor body 410. The second sloped portion 436 canbe configured to provide a cam surface for the expander (not shown) tofacilitate movement of the expander (not shown) down the axial bore 416and to thereby facilitate expansion of the radius of the second end 414of the anchor body 410 from radius r5 to radius r7. In some embodiments,the second end 414 of the anchor body 410 achieves an expanded radius ofapproximately 40 millimeters, 20 millimeters, 10 millimeters, 7.2millimeters, 5 millimeters, 2 millimeters, 1 millimeter, or any otherdesired diameter.

An anchor can be used with a variety of expanders. FIG. 4 depicts oneembodiment of an expander 700 comprising an expansion member 702 havinga first end 710 and a second end 712. An expansion member 702 can haveone or more features configured to cause expansion of an anchor bodywhen the expander 700 is longitudinally displaced into the anchor body.The expander 700 depicted in FIG. 4 has a spreading head 714 having aradius r8 and located proximate to the first end 710 of the expansionmember 702. The spreading head 714 can be manufactured to any desiredsize and shape. As depicted in FIG. 4, spreading head 714 can comprise aconical frustum having a base 716 located at the first end 710 of theexpander. A person of skill in the art will recognize that the shape andsize of the head 714 will affect the ultimate degree and shape ofexpansion of the anchor body, as well as the requisite forces tolongitudinally displace the expander 700 within the anchor body.

In some embodiments, an expansion member 702 can include a shaft 718having a diameter r9. As depicted in FIG. 4, shaft 718 can extendlongitudinally from the spreading head 714 to the second end 712 of theexpansion member 702. Shaft 718 can have a variety of sizes and shapes.The shaft 718 depicted in FIG. 7 is a conical shaft. In someembodiments, the shaft 718 can have a diameter r9 configured to fitwithin the axial bore of an anchor body without causing expansion of theanchor body. Thus, in some embodiments, expander 700 can benon-expandingly disposed within the axial bore of the anchor body whenthe shaft 718 is located in the axial bore and features of the expansionmember 702 configured for expanding the anchor body are positioned so asto not cause expansion of the anchor body.

In some embodiments, and as depicted in FIG. 4, the shaft 718 cancomprise a caming surface 720. In some embodiments, caming surface 720can, for example, facilitate placement of the expander 700 in an axialbore of an anchor, or facilitate the expansion of the anchor body.

In some embodiments, an expander 700 can include features to facilitateapplication of forces to the expander 700 to affect deployment of theanchor. In some embodiments, an expander 700 can comprise a threadedhole in the second end 712 configured for threading engagement with athreaded portion of the insertion tool. In some embodiments of an anchorin which the anchor is deployed or expanded by the proximal movement ofthe expander 700 relative to the anchor, the anchor body can abut with aportion of the insertion tool so as to prevent movement of the anchorbody relative to the insertion tool. The expander 700 can be connectedto a portion of the insertion tool that is relatively movable ascompared to the portion of the insertion tool against which the anchorbody abuts. In some embodiments, the abutting interaction of the anchorbody and the insertion tool, and the connection of the expander 700 to arelatively movable portion of the insertion tool can allow thelongitudinal displacement of the expander from a first, undeployed,unexpanded position proximate to the distal end of the anchor toward theproximate end of the anchor and to a second, deployed, expandedposition.

An expander can include features configured for engaging with andcapturing material to be secured to the bone, such as, for example,tissue or a suture. These features can be located on a variety ofportions of the expansion member 702, including, for example, the head714, shaft 718, or any other feature configured for expansion.

FIG. 5 depicts one embodiment of a single piece expander 800 comprisingand expansion member 802 having a first end 810 and a second end 812.The expansion member 802 further comprises a spreading head 814 having aradius r10 and having a base 816, a first shaft portion 818 having aradius r11, an spreading shoulder 820 having a radius r12, and a secondshaft portion 822 having a radius r13. The spreading head 814 depictedin FIG. 8 comprises a conical frustum having a base at the first end 810of the single piece expander 800. The base 816 of the spreading head 814depicted in FIG. 5, is radially elevated above the first shaft portion818, above the spreading shoulder 820, and above the second shaftportion 822, in that the radius r10 of the base 816 of the spreadinghead 814 is larger than the radius r11 of the first shaft portion 818,larger than the radius r12 of the spreading shoulder 820, and largerthan the radius r13 of the second shaft portion 822. The spreading head814 can comprise a variety of sizes and shapes and a variety of relativesizes according to application requirements for an anchor.

The expansion member 802 depicted in FIG. 5 comprises a spreadingshoulder located between the first end 810 and the second end 812 of thesingle piece expander 800. However, in other embodiments, the spreadingshoulder 820 can be located in other positions on the single pieceexpander 800, including, at the second end 812 of the single pieceexpander 800. The spreading shoulder 820 depicted in FIG. 5 is radiallyelevated above the first shaft portion 818 and above the second shaftportion 822 in that the radius r12 of the spreading should 820 is largerthan the radius r11 of the first shaft portion 818 and larger than theradius 813 of the second shaft portion 822. The spreading shoulder 822can comprise a variety of sizes and shapes and a variety of relativesizes according to application requirements for an anchor. In someembodiments, the spreading shoulder 822 can be radially smaller than,radially equal to, or radially larger than the base 816 of the spreadinghead 814, than the first shaft portion 818, or than the second shaftportion 822. Likewise, the shapes and dimensions of the other featuresof the single piece expander can be varied to achieve desired results.

FIG. 5A depicts a perspective cut-away view of an anchor 850 comprisingan anchor body 852 and an expander 800 in an expanded or deployedconfiguration.

The expander depicted in FIG. 5A comprises an expansion member 802having a first end 810 and a second end 812. The expansion member 802further comprises a spreading head 814 having a base 816 located at thefirst end 810. The expansion member additionally comprises a camingsurface 820 located proximate to the second end 812 of the expansionmember 802 and between the first end 810 of the expansion member 802 andthe second end 812 of the expansion member 802.

The anchor body 852 depicted in FIG. 5A comprises a first end 854, asecond end 856, an axial bore 858, first tines 860 and first expansionslots 862, second tines 864 and second expansion slots (not shown). Theaxial bore 858 of the anchor body 852 depicted in FIG. 8A also has afirst stop 868 and a earning abutment 870.

As depicted in FIG. 5A, the expander 800 is wholly positioned within theaxial bore 858 of the anchor body 850. Specifically, the expander 800 ispositioned within the axial bore 858 of the anchor body 850 such thatthe first stop 868 prevents movement of the expander 800 towards thefirst end 854 of the anchor body 850 by abuttingly engaging with thebase 816 of the spreading head 814 of the expander 800.

As depicted in FIG. 5A, the spreading head 814 and other portions of theexpander 800 expandingly engage with portions of the axial bore todeploy or expand the anchor body 850.

FIG. 6 depicts one embodiment of a two piece expander 900 comprising afirst expansion member 902 and a second expansion member 904. In someembodiments, a two piece expander 900 can include features to facilitateapplication of forces to the expander 900 to affect deployment of theanchor. In some embodiments of an anchor in which the anchor isdeployed, or expanded, by the movement of the expander 900 relative tothe anchor, the anchor body can abut with a portion of the insertiontool so as to prevent movement of the anchor body relative to theinsertion tool. The pieces of the expander 900 can be connected to oneor multiple portions of the insertion tool that are relatively movableas compared to the portion of the insertion tool against which theanchor body abuts. In some embodiments, the abutting interaction of theanchor body and the insertion tool, and the connection to the pieces ofthe expander 900 allow the relatively movable portion of the insertiontool to longitudinally displace the expander pieces from a first,undeployed, unexpanded position to a second, deployed, expandedposition.

The first expansion member has a first end 910 and a second end 912. Thefirst expansion member 902 has a first spreading head 914 having a base916 defined by a radius r14, and a first shaft portion 918 defined by aradius r15. The first spreading head 914 depicted in FIG. 9 comprises aconical frustum having a base 916 at the first end 910 of the firstexpansion member 902 of the double piece expander 900. The base 916 ofthe first spreading head 914 depicted in FIG. 6, is radially elevatedabove the first shaft portion 918 in that the radius r14 of the base 916of the first spreading head 914 is larger than the radius r15 of thefirst shaft portion 918. The first spreading head 914 can comprise avariety of sizes and shapes and a variety of relative sizes according toapplication requirements for an anchor.

The second expansion member 904 has a first end 920 and a second end922. The second expansion member 904 has a second spreading head 924having a base 926 defined by a radius r16, and a second shaft portion928 defined by a radius r17. The second spreading head 924 depicted inFIG. 6 comprises a conical frustum having a base 926 at the first end920 of the second expansion member 904 of the double piece expander 900.The base 926 of the second spreading head 924 depicted in FIG. 6, isradially elevated above the second shaft portion 928 in that the radiusr16 of the base 926 of the second spreading head 924 is larger than theradius r17 of the second shaft portion 928. The second spreading head924 can comprise a variety of sizes and shapes and a variety of relativesizes according to application requirements for an anchor. The first andsecond spreading heads 914, 924 can comprise a variety of sizes andshapes and a variety of relative sizes according to applicationrequirements for an anchor. In some embodiments, the base 916 of thefirst spreading head 914 can be radially smaller than, radially equalto, or radially larger than the base 926 of the second spreading head924. Similarly, the relative sizes of the first shaft portion 918 andthe second shaft portion 928 can vary with respect to each other andwith respect to the first and second spreading heads 914, 924.

In some embodiments of a double piece expander 900, the second expansionmember can comprise a thru-hole 930. The thru-hole can be sized andshaped to allow a portion of the insertion tool configured forattachment to the first expansion member 902 to pass through the secondexpansion member 904.

In some additional embodiments, the second end 922 of the secondexpansion member 904 can be configured for abutting contact with aportion of an insertion tool. In some embodiments, the portion of theinsertion tool can be configured to allow movement of the secondexpansion member 904 relative to the anchor body.

FIG. 6A depicts a perspective cut-away view of an anchor 950 in anexpanded or deployed configuration comprising an anchor body 952 and adouble piece expander 900.

The double piece expander 900 depicted in FIG. 6A comprises a firstexpansion member 902 and a second expansion member 904. The firstexpansion member 902 has a first end 910 and a second end 912 andcomprises a first spreading head 914 having a base 916 located at thefirst end 910. The second expansion member 904 has a first end 920 and asecond end 922 and comprises a second spreading head 924 having a base926 located at the first end 920.

The anchor body 952 depicted in FIG. 6A comprises a first end 954, asecond end 956, an axial bore 958, first tines 960 and first expansionslots 962, second tines 964 and second expansion slots (not shown). Theaxial bore 958 of the anchor body 952 depicted in FIG. 6A also has afirst stop 968 and a second stop 970.

As depicted in FIG. 6A, the expander 900 is wholly positioned within theaxial bore 958 of the anchor body 950. Specifically, the expander 900 ispositioned within the axial bore 958 of the anchor body 950 such thatthe first stop 968 prevents movement of first expansion member 902towards the first end 954 of the anchor body 950 by abuttingly engagingwith the base 916 of the first spreading head 914 of the first expansionmember 902. The second expansion member 904 of the expander 900 ispositioned within the axial bore 958 of the anchor body 950 such thatthe second stop 970 prevents movement of second expansion member 904towards the second end 956 of the anchor body 950 by abuttingly engagingwith the second spreading head 924 of the second expansion member 904.As additionally depicted in FIG. 6A, the first expansion member 902 isnot in contact with second expansion member 904. However, a person ofskill in the art will recognize that in some embodiments, a firstexpansion member 902 may be in contact with a second expansion member904.

As depicted in FIG. 6A, the first spreading head 914 and the secondspreading head 924 expandingly engage with portions of the axial bore todeploy or expand the first tines 960 and first expansion slots 962located at the first end 954 of the anchor body 950 and the second tines964 and second expansion slots 966 located at the second end 956 of theanchor body 950 respectively.

The above described dual expansion anchor can be made from a variety ofmaterials, including, natural, or manmade materials. The dual expansionanchor can be made of metal, plastic, polymer, composite, or othermaterials. In some embodiments, the anchor is made of a biocompatiblepolymer, plastic, or metal. Other embodiments include a tissue captureanchor entirely or in part of a non-metallic substance that isbiocompatible. Biocompatible materials such as poly ether ketone (PEK),polyether ether ketone (PEEK), polyetherimide (ULTEM), ultrahighmolecular weight polyethylene (UHMPE), polyphenylene, or some otherengineering polymer materials known to those of skill in the art may beused. A non-metallic anchor system may provide certain advantages suchas, for example, eliminating MRI artifacts.

Tissue Capture

Some embodiments include using an anchor described above to capture andsecure soft tissue, such as a tendon or ligament, prior to insertion ofthe anchor into bone. In some embodiments, soft tissue can be secured tothe anchor using a loop of suture that passes around soft tissue or asoft tissue bundle. In some embodiments, manipulation of the suture toachieve the secured configuration can be accomplished using a suturegrabber that is associated with the anchor. In some embodiments, thesuture grabber extends from a distal end of the anchor. In someembodiments, the suture grabber is retractable into the anchor so as topull a suture limb into the anchor. Suitable suture grabbers caninclude, but are not limited to, a wire loop, a wire hook, a pinchermechanism, or any other suitable structure. In some embodiments, thesuture grabber is formed from a nitinol wire. In any of the embodimentsutilizing a particular suture grabber as described herein (e.g., a wireloop), it is to be understood that any other suitable suture grabber maybe utilized.

FIGS. 17A through 19E depict embodiments of methods of securing softtissue, such as, for example, a tendon or ligament, to an anchor 2500which can be connected to an inserter tool 1000. The anchor 2500 cancomprise any of the anchors discussed above, or any other desiredanchor. As depicted in FIG. 17A, the anchor 2500 comprises an expander750 including a suture 757 and a wire loop 788. The suture 757 extendsfrom the anchor through a first hole on the distal end of the anchorexpander 750. The wire loop 788 extends from the anchor through a secondhole on the distal end of the anchor expander 750. The suture may extendproximally through the interior of the anchor 2500 and the interior ofthe inserter tool 1000 to a position where it can be held andmanipulated by a surgeon. Similarly, the ends of the wire loop 788 mayextend proximally through the interior of the anchor 2500 and theinterior of the inserter tool 1000 to a position where they can be heldand manipulated by a surgeon. As depicted in FIG. 17A, the anchor 2500can be inserted through a first arthroscopic port 2502 to a positionproximate to, for example, a tendon 2504. After the anchor 2500 has beenpositioned proximate to a tendon 2504, the process proceeds to FIG. 17Band the wire loop 788 can be pulled through a second arthroscopic port2506. In some embodiments, a tool can be reached through the firstarthroscopic port 2502 or the second arthroscopic port 2506 and can beused to grasp the wire loop 788 and to pull the wire loop through thesecond arthroscopic port 2506.

After the wire loop 788 is pulled through a second arthroscopic port2506, the process proceeds to FIG. 17C, in which the suture 757 can bepassed under the, for example, tendon 2504. In some embodiments, a toolcan be reached through the first arthroscopic port 2502 or the secondarthroscopic port 2506 and can be used to grasp the suture 757 to passthe suture 757 under the tendon 2504. After the suture 757 is passedunder the tendon 2504, the process proceeds to FIG. 17D, and the suture757 is pulled through the second arthroscopic port 2506. As discussedabove, a tool can access the suture 757 via one of the arthroscopicports 2502, 2506 and can pull the suture 757 out of the secondarthroscopic port. After the suture 757 is pulled through the secondarthroscopic port 2506, the suture 757 can be passed through or tied tothe wire loop 788.

Next, the wire loop 788 may be retracted (e.g., by pulling on the endsof the wire that extend through the anchor inserter 1000) down throughthe arthroscopic port 2506, through the interior of the anchor 2500 andinterior of the inserter 1000, and out of the patient's body in thevicinity of the inserter 1000. Advantageously, the retraction of thewire loop 788 through these features can likewise retract the limb ofthe suture 757 that extends through port 2506 through these features.After the wire loop 788 is retracted, pulling the suture 757 with it,the process moves to FIG. 17E and the tendon 2504 is secured to theanchor 2500 by the suture 757 which forms a loop around the tendon 2504with its two suture limbs extending through the interior of the anchor2500 and the interior of the inserter 1000. In some embodiments, thetendon may be temporarily and adjustably secured to the anchor bycreating tension on the two suture limbs. This tension may be manuallycreated by a surgeon pulling on the suture limbs or the suture limbs maybe secured to a portion of the inserter 1000, such as suture cleatslocated on a handle of the inserter 1000.

FIGS. 18A through 18E depict another method of securing soft tissue toan anchor 2500. As depicted in FIG. 18A, the anchor 2500 comprises awire loop 788 and a suture 757. The suture 757 extends from the anchorthrough a first hole on the distal end of the anchor expander 750. Thewire loop 788 extends from the anchor through a second hole on thedistal end of the anchor expander 750. The suture may extend proximallythrough the interior of the anchor 2500 and the interior of the insertertool 1000 to a position where it can be held and manipulated by asurgeon. Similarly, the ends of the wire loop 788 may extend proximallythrough the interior of the anchor 2500 and the interior of the insertertool 1000 to a position where they can be held and manipulated by asurgeon. The suture 757 is inserted through the first arthroscopic port2502 to a position proximate to, for example, the tendon 2504. Asfurther depicted in FIG. 18A, the suture 757 can, in some embodiments,extend through the expander 750 of the anchor 2500 and out the firstarthroscopic port 2502. In some embodiments, the two limbs of the suture757 can be affixed, for example, to the cleats on the inserter 1000.

After the anchor 2500 is positioned proximate to the tendon 2504, theprocess proceeds to FIG. 18B and the wire loop 788 is passed under, forexample, the tendon 2504. After the wire loop 788 is passed under thetendon 2504, the process proceeds to FIG. 18C, and the wire loop 788 ispulled through the second arthroscopic port 2506. After the wire loop788 is pulled through the second arthroscopic port 2506, the processproceeds to FIG. 18D, in which the suture 757 can be released from acleat on the inserter, and the suture can be pulled through the secondarthroscopic port 2506 and passed through the wire loop 788. Next, thewire loop 788 may be retracted (e.g., by pulling on the ends of the wirethat extend through the anchor inserter 1000) down through thearthroscopic port 2506, through the interior of the anchor 2500 andinterior of the inserter 1000, and out of the patient's body in thevicinity of the inserter 1000. Advantageously, the retraction of thewire loop 788 through these features can likewise retract the limb ofthe suture 757 that extends through the port 2506 through thesefeatures. After the wire loop 788 is retracted, pulling the suture 757with it, the process moves to FIG. 18E and the tendon 2504 is secured tothe anchor 2500 by the suture 757 which forms a loop around the tendon2504 with its two suture limbs extending through the interior of theanchor 2500 and the interior of the inserter 1000. In some embodiments,the tendon may be temporarily and adjustably secured to the anchor bycreating tension on the two suture limbs. This tension may be manuallycreated by a surgeon pulling on the suture limbs or the suture limbs maybe secured to a portion of the inserter 1000, such as suture cleatslocated on a handle of the inserter 1000.

FIGS. 19A through 19E depict an additional method of securing softtissue to an anchor 2500. As depicted in FIG. 19A, the anchor 2500comprises an expander 750 including a wire loop 788. The wire loop 788extends from the anchor through a first hole on the distal end of theanchor expander 750. The ends of the wire loop 788 may extend proximallythrough the interior of the anchor 2500 and the interior of the insertertool 1000 to a position where they can be held and manipulated by asurgeon. As depicted in FIG. 19A, the anchor 2500 is inserted throughthe first arthroscopic port 2502 to a position proximate to, forexample, the tendon 2504. After the anchor 2500 is positioned proximateto the tendon 2504, the process then proceeds to FIG. 19B and a suture757 is passed through the second arthroscopic port 2506 and passedaround the tendon 2504. The passing of the suture 757 through the secondarthroscopic port 2506 can be performed using any of a number of toolsand techniques. After the suture 757 is passed around the tendon 2504,the process proceeds to FIG. 19C, and the wire loop 788 is pulledthrough the second arthroscopic port 2506. After the wire loop 788 ispulled through the second arthroscopic port 2506, the suture 757 can bepassed through the wire loop 788. In some embodiments, a sufficientlylength of suture 757 is passed through the wire loop 788 to allow thewire loop 788 to reliably retract the suture 757 through the secondarthroscopic port 2506 and through the anchor 2500 and the inserter tool1000. After the suture 757 is passed through the wire loop 788, theprocess proceeds to FIG. 19D, in which the wire loop 788 may beretracted (e.g., by pulling on the ends of the wire that extend throughthe anchor inserter 1000) down through the second arthroscopic port2506. As seen in FIG. 19D, the retraction of the wire loop 788 throughthe second arthroscopic port 2506 likewise retracts a portion of thesuture 757 through the second arthroscopic port 2506. Next, the wireloop 788 can further be retracted (e.g., by pulling on the ends of thewire that extend through the anchor inserter 1000) through the interiorof the expander 750, the interior of the anchor 2500, and the interiorof the inserter tool 1000, and out of the patient's body in the vicinityof the inserter 1000. Advantageously, the retraction of the wire loop788 through these features can likewise retract the limb of the suture757 that extends through the port 2506 through these features. After thewire loop 788 is retracted, pulling the suture 757 with it, the processmoves to FIG. 19E and the tendon 2504 is secured to the anchor 2500 bythe suture 757, which forms a loop around the tendon 2504 with its twosuture limbs extending through the interior of the anchor 2500 and theinterior of the inserter 1000. In some embodiments, the tendon may betemporarily and adjustably secured to the anchor by creating tension onthe two suture limbs. This tension may be manually created by a surgeonpulling on the suture limbs or the suture limbs may be secured to aportion of the inserter 1000, such as suture cleats located on a handleof the inserter 1000.

Anchor Inserter Tool

FIG. 7 depicts individual components of one embodiment of an insertertool. An inserter tool comprises a range of features configured to allowthe inserter tool to insert an anchor and then deployingly interact withthe anchor. One embodiment of an inserter tool may be configured for usewith a specific anchor configuration, or with a specific spreaderconfiguration. FIG. 10 depicts an embodiment of an inserter configuredfor use with a single piece expander. The inserter tool comprises aninner rod or tube 1100, an outer tube 1200, a handle body 1300, athreaded actuator shaft 1400, and a deployment knob 1500. In someembodiments, the inserter 1000 is coupled to the anchor duringmanufacturing. In a preferred embodiment, the inserter tool isdisposable.

The inserter tool 1000 is designed to insert and manipulate an anchorsuch as the anchor described in FIGS. 1 through 3. In some embodiments,the anchor is manufactured to be attached to an inserter tool beforepackaging. In other embodiments, the tissue capture anchor is coupled tothe inserter tool prior to insertion. In a basic configuration, theinserter tool is assembled as follows: the inserter tool 1000 isconfigured such that the inner rod 1100 is disposed within the outertube 1200. The outer tube is configured to fit against the proximal endof the anchor. The inner rod 1100 extends through outer tube 1200 and isconfigured to attach to the expander via threading on both the proximalhole in the expander and threading on the distal end of the inner rod1100. The proximal end of the outer tube 1200 is connected to a handle1300 and the inner rod 1100 extends through the proximal end of theouter tube 1200 and screws into the threaded actuator shaft 1400. Theactuator shaft 1400 extends just past the proximal end of the handle1300 where it is configured to secure with a deployment knob 1500.

The individual components of the inserter tool are further described indetail below.

FIG. 7A depicts an embodiment of an inserter configured for use with atwo piece expander. Like the inserter tool 1000 depicted in FIG. 7,inserter tool 1000 a comprises an inner rod or tube 1100 a, an outertube 1200 a, a handle body 1300 a, a threaded actuator shaft 1400 a, anda deployment knob 1500 a. In some embodiments, the inner rod or tube1100 a, the outer tube 1200 a, the handle body 1300 a, the threadedactuator shaft 1400 a, and the deployment knob 1500 a of inserter tool1000 a can fit together as described in relation to those features ofFIG. 7. In some embodiments, some or all of the inner rod or tube 1100a, the outer tube 1200 a, the handle body 1300 a, the threaded actuatorshaft 1400 a, and the deployment knob 1500 a of inserter tool 1000 a caninclude additional features configured to facilitate use with a twopiece expander. These differences can include, for example, additionalfeatures located on the outer tube 1200 a, or on any other feature ofthe inserter tool 100 a. Additional features of the outer tube 1200 awill be discussed in greater detail below.

FIG. 8 shows a perspective view of an embodiment of the inner rod 1100.In some embodiments, the inner rod is an inner tube. The inner rodcomprises a distal end configured to secure to the expander, a proximalend which is configured to interact with the other components of theinserter, for instance the actuator shaft 1400. The inner rod 1100 isconfigured that a proximal end 1120 is advanced through the outer tube1200 and into the handle 1300 where it is further secured within theactuator shaft 1400 via threading. The distal end 1105 of the inner rod1100 is configured to be advanced through the central hole in the anchorbody and then secured to the expander until the anchor is fully deployedand the inner rod 1100 is separated from the anchor. In someembodiments, the distal end 1106 can comprise features configured toengage with the expander, such as, for example, threads 1110. The body1125 of the inner rod 1100 is configured for sliding positioning withinouter tube 1200.

The inner rod 1100 extends through the central hole in the anchor bodybefore coupling with the expander. In one embodiment, the inner rod 1100couples with the expander through threads on the end of the inner rod1100 and within the proximal end of the expander. In other embodiments,the inner rod 1100 may couple to the expander through other securingmechanisms such as adhesives, welding or frictional fit.

FIG. 9 shows an embodiment of the outer tube 1200. The outer tube 1200is attached at its proximal end 1205 to the distal end of handle viathreading 1225. The distal end 1210 of the outer tube 1200 is configuredsuch that the inner rod is drawn into the outer tube 1200 and throughopening 1220 in the distal end 1210 of outer tube 1200 where it issecured to the expander. When the inner tube is advanced far enough thatthe expander locks into place or cannot advance anymore, the outer tube1200 distal surface is surface-to-surface with the proximal surface ofthe anchor body. When the inner rod withdraws further into the outertube upon the continued rotation of the deployment knob and advancementof the actuator shaft, the inner rod strips the threading from theexpander and the inserter tool detaches from the anchor.

FIG. 9A shows an embodiment of the outer tube 1200 a configured for usewith a two piece expander. The outer tube 1200 a is attached at itsproximal end 1205 a to the distal end of handle via threading 1225 a.The distal end 1210 a of the outer tube 1200 a is configured such thatthe inner rod is drawn into the outer tube 1200 a and through opening1220 a of the distal end 1210 a of outer tube 1200 a where it is securedto the expander. In some embodiments of an outer tube 1200 a configuredfor use with a two piece expander, the distal end 1210 a of the outertube comprises a first abutment 1212 a. In some embodiments, the firstabutment 1212 a is configured for abutting engagement with the secondend 114, 414 of a dual expansion anchor 100, 400.

In some embodiments, the distal end 1210 a of the outer tube 1200 acomprises a first base 1260 a and a first elevated abutment 1262 a. Insome embodiments, the first base 1260 is sized and dimensioned to fitwithin portions of the axial bore 116, 416 proximate to the second end114, 414 of anchor 100, 400. The first base 1260 a can be, for example,sized and shaped to slidably enter portions of the axial bore 116, 416proximate to the second end 114, 414 of the dual expansion anchor 100,400 when the dual expansion anchor 100, 400 is in its deployed orexpanded configuration, or, alternatively, to slidably enter portions ofthe axial bore 116, 416 proximate to the second end 114, 414 of the dualexpansion anchor 100, 400 when the dual expansion anchor 100, 400 is inits undeployed or unexpanded configuration. In some embodiments, thefirst elevated abutment 1262 a of the outer tube 1200 a is configuredfor abutting engagement with the second end 922 of the second expansionmember 904.

In some embodiments, the distal end 1210 a of the outer tube 1200 acomprises a second base 1270 a and a second elevated abutment 1272 a. Insome embodiments, the second base 1270 a is sized and dimensioned to fitwithin portions of the axial bore 116, 416 proximate to the second end114, 414 of anchor 100, 400. In some embodiments, second base 1270 a isconfigured to slidingly extend through a thru-hole in the secondexpansion member 904. In some embodiments, the second base 1270 a can besized and configured to extend through the second expansion member 904.In some embodiments, the second base 1270 a terminates at a point withinthe axial bore 116, 416 of the anchor 100, 400 where the second elevatedabutment 1272 a abuts the second end 912 of the first expansion member902 when the dual expansion anchor is in its deployed or expandedconfiguration.

In some embodiments, the features of the distal end 1210 a of the outertube 1200 a are configured to facilitate deployment of a dual expansionanchor 100, 400 with a two piece expander 900. In some embodiments, adual expansion anchor 100, 400 can be positioned on the distal end 1210of the outer tube 1200 a of an inserter tool 1000 a. Specifically, insome embodiments, the second expansion member 904 of a dual expansionanchor 100, 400 can abut the first elevated abutment 1262 a. In someembodiments, the second base 1270 a and the inner tube 1100 a can extendthrough a thru-hole in the second expansion member 904 of a dualexpansion anchor 900. In some embodiments, a second end 114, 414 of theanchor body 110, 410 can contact the second expansion member 904 of thetwo piece expander 900 and the first end 112, 412 of the dual expansionanchor 100, 400 can contact the first expansion member 902 of the twopiece expander 900. In some embodiments the first expansion member 902of the two piece expander 900 can be affixed to the inner tube 1100 a.When the inner tube 1100 a is longitudinally displaced to expand/deploythe anchor 100, 400, the inner tube 1100 a applies a force to the firstexpansion member 902 of the two piece expander 900 while the firstelevated abutment 1262 a applies a reactionary force to the secondexpansion member 904 of the two piece expander 900. The application ofthese forces can displace the first and second expansion members 902,904 of the two piece expander 900 until both the first and secondexpansion members 902, 904 of the two piece expander 900 are in theirdeployed position. More specifically, the first expansion member 902 ofthe two piece expander 900 can displace under applied forces until thefirst expansion member 902 of the two piece expander 900 contacts thesecond elevated abutment 1272 a. Additionally, the second expansionmember 902 of the two piece expander 900 can displace under the appliedforces until second end 114, 414 of the anchor body 110, 410 contactsthe first abutment 1212 a of the distal end 1210 a of the outer tube1200 a. In some embodiments, the second elevated abutment 1272 a can bepositioned relative to the first elevated abutment 1262 a, and the dualexpansion anchor 100, 400 can be designed such that the first expansionmember 902 of the two piece expander 900 only contacts the secondelevated abutment 1272 a after the second end 114, 414 of the anchorbody 110, 410 contacts the first abutment 1212 a of distal end 1210 a ofthe outer tube 1200 a. After both the first and second expansion members902, 904 of the two piece expander 900 reach their deployed/expandedpositions, the inner tube 1100 a is separated from the first expansionmember 902 of the two piece expander 900, and the connection between theinserter tool 1000 a and the anchor 100, 400 is terminated.

FIGS. 10A and 10B show embodiments of a handle body 1300. A handle body1300 can comprise a handle piece 1302 and a lid piece 1304. FIG. 10A isa side view of a lid piece 1304 of the handle body 1300. The proximalend of the handle 1300 is configured to receive the deployment knob viathe ridges 1330 which hold the knob secure. The actuator shaft is housedwithin the handle body 1300. A set of flat brackets or braces 1310secure the actuator shaft within the handle 1300. The distal end of thehandle 1300 is configured to receive the outer tube via threads atopening 1350. The outer tube is permanently affixed to the handle 1300at its distal end.

FIG. 10B depicts a perspective view of one embodiment of the handleportion 1302 of a handle 1300. Handle portion 1302 includes a threadedhole for threading engagement with threading 1225 of the outer tube1200. Handle portion 1302 depicted in FIG. 10B further includes bracereceiving openings 1312. Handle portion 1302 additionally includes flatsurfaces 1315.

FIG. 11 depicts the threaded actuator shaft 1400. The actuator shaft1400 is comprised of a distal end 1405 comprising a threaded hole 1410which is configured to receive the inner rod 1100, a second threadedportion 1425 on the body of the shaft configured to advance the innerrod 1100, and a proximal end 1420 configured to secure within thedeployment knob 1500. The threading 1425 of the actuator 1400 has twoflat areas 1430, one on each side, where there is no threading. Theseflat areas 1430 fit within the flat surfaces 1315 of the handle 1300such that the actuator 1400 cannot rotate within the handle.

The body of the actuator shaft 1400 is configured with threading 1425 topermit the shaft 1400 to advance the inner tube 1100. The body of theactuator shaft 1400 is not perfectly round, but rather is oval shapedwith flat sides 1430 that are fit into the handle body 1300 in such away that the actuator shaft 1400 cannot itself rotate when thedeployment knob 1500 is turned and the shaft 1400 advances via knob1500. Thus, the threads do not go all the way around the shaft butrather flatten out on the flattened sides of the shaft. The actuatorshaft is configured as a coaxial system. That is, the expander, innertube 1100 and actuator 1400 are configured to operate as one piece. Theflat surfaces 1315 in the handle make the actuator shaft 1400 stay onplane such that the actuator shaft 1400 itself cannot rotate within thehandle 1300. The proximal end of the inner tube 1100 couples with thedistal end of the actuator shaft 1400 via threading.

Moving to FIG. 12, a deployment knob 1500 is shown. The deployment knob1500 comprises a central hole 1510 which is configured with threading1505, and a groove 1530 configured to be received by a correspondingridge 1330 of the handle 1300. The threading 1505 in the central hole1510 is configured to receive the actuator shaft 1400. The deploymentknob 1500 is configured to advance, relative to the deployment knob1500, the inner rod 1100 via the actuator shaft 1400. The actuator shaft1400 is joined at its proximal end to the distal end of the deploymentknob 1500 via threading 1505 in the central hole 1510. The actuatorshaft 1400 is attached to the inner rod 1100 by way of the proximal endof the inner rod 1100 advancing into the distal end of the actuatorshaft via threading so that when the deployment knob 1500 is rotated,the mechanism of the shaft 1400 advances the inner rod 1100 proximallysuch that the expander is then advanced into the anchor body to expandthe anchor body into bone and secure the anchor.

In one embodiment, the deployment knob 1500 is threaded 1505 to receivethe actuator shaft via the groove 1530 of knob 1500 fitting with theproximal end ridge 1330 of the handle body 1300 As the deployment handleis turned, the actuator shaft 1400 is advanced in a proximal directionuntil the anchor body is deployed and locked into place.

FIG. 13A shows one embodiment of a dual expansion anchor 400 coupled tothe inserter tool 1000. The anchor 400 comprises the anchor body 410 andthe expander 480. As seen in FIG. 13A, the expander 480 comprises a wireloop 788 and a suture 757. As further seen in FIG. 13A, the insertertool 1000 includes a cleat 1450. In some embodiments, the inserter tool1000 can comprise one or several cleats 1450, which can be located, forexample, on any desired portion of the inserter tool 1000. In someembodiments, the cleat 1450 can be configured to facilitate in securingthe suture 757, and specifically, the cleat 1450 can be used to secureone or both ends of the suture 757. In one specific embodiment, theinserter tool 1000 can comprise a first cleat located on the side of thehandle body 1300, and a second cleat can be located at a position on thehandle body 1300 between the handle body 1300 and the outer tube 1200.In such an embodiment, the first cleat can secure a first end of thesuture 757 and the second cleat can secure a second end of the suture757. A person of skill in the art will recognize that any of the abovedisclosed, or other features configured for engaging with and capturingmaterial to be secured to the bone can be used in connection with a dualexpansion anchor 400 coupled to an inserter tool 1000.

The inserter tool 1000, as shown, includes the outer tube 1200, thehandle 1300 and the deployment knob 1500. The inner rod 1100 ispositioned within the outer tube 1200, and the outer tube is flush withthe anchor body 410. The outer tube 1200 may hold the anchor body 410steady during insertion and deployment. The inner rod 1100 extendsthrough the anchor body 410 and couples with the expander 480 viathreading. The expander 480 is configured to be advanced through thedistal end of the anchor body 410 by the inner rod 1100 via a rotatingthe deployment knob 1500.

In another embodiment, the inner rod 1100 extends through the expander480. The inner rod 1100 is configured with a sharp, pointed tip suchthat the tip of the inner rod 1100 spears or captures tissue to secureinto the bone hole before the anchor body 410 is fully deployed.

The inner rod 1100 provides the mechanism to draw the expander 480 intothe central bore 416 in the anchor body 410 to fully expand the anchorbody 410. During deployment of the tissue capture anchor 400, the innerrod 1100 is continually advanced via a screwing motion until theexpander locks with the anchor body. As the deployment knob 1500continues to turn and the inner rod 1100 continues to pull on thethreads of the expander 480, the inner rod 1100 strips the threads fromthe inside of the expander 480 and the insertion tool 1000 releases fromthe anchor body 410. Any thread shavings are contained within the outertube 1200.

FIG. 14 illustrates an exploded view of the anchor 100 and the inserter1000. The tissue capture anchor 100 comprises the anchor body 110 andthe expander 180. The inserter tool 1000, as shown, includes the outertube 1200, the handle 1300 and the deployment knob 1500. The inner rod1100 is positioned within the outer tube 1200, and the outer tube isflush with the anchor body 110. The outer tube 1200 may hold the anchorbody 110 steady during insertion and deployment. The inner rod 1100extends through the anchor body 110 and couples with the expander 180via threading. The expander 180 is configured to be advanced through thedistal end of the anchor body 110 by the inner rod 1100 via a rotatingthe deployment knob 1500.

The inner rod 1100 provides the mechanism to draw the expander 180 intothe central hole in the anchor body 110 to fully expand the anchor body110. During deployment of the tissue capture anchor 100, the inner rod1100 is continually advanced via a screwing motion until the expanderlocks with the anchor body. As the deployment knob 1500 continues toturn and the inner rod 1100 continues to pull on the threads of theexpander 180, the inner rod 1100 strips the threads from the inside ofthe expander 180 and the insertion tool 1000 releases from the anchorbody 110. Any thread shavings are contained within the outer tube 1200.

In some embodiments, a pre-attached delivery handle is provided. In someembodiments, the insertion tool or delivery handle is disposable. Inother embodiments, the insertion tool can be sterilized, reloaded andreused.

Those of skill in the art will appreciate other inserters and mechanismsthat may be used to insert and deploy the dual expansion anchor 100,400described herein.

Although a particular inserter device for inserting and manipulatingdual expansion anchor 100,400 has been described, it should beunderstood that other inserter designs may be used for manipulating theparts of dual expansion anchor 100,400 described above to insert theanchor into bone and tissue to the bone. For example, it may be possibleto use separate tools for inserting the anchor and deploying the anchor.

It will be appreciated that there are numerous combinations of anchorsand their placement that may be used to secure soft tissue to bone bythe methods and devices described herein. These variations as well asvariations in the design of the above described anchor devices andinserter devices are within the scope of the present disclosure.

Methods of Attaching Soft Tissue to Bone

Various embodiments include methods for attaching soft tissue to bone.In some embodiments, the methods include using the tissue captureanchors described above. In one preferred embodiment, a biceps tenodesisprocedure is performed arthroscopically.

The biceps tendon connects the biceps muscle to the bone. The bicepstendon connects the biceps muscle to the bone. The tendon passes fromthe muscle to the shoulder joint. Biceps tendon problems can also occurin conjunction with a rotator cuff tear.

A biceps tenodesis is a procedure that cuts the normal attachment of thebiceps tendon on the shoulder socket and reattaches the tendon to thebone of the humerus (arm bone). By performing a biceps tenodesis, thepressure of the biceps attachment is taken off the cartilage rim of theshoulder socket (the labrum), and a portion of the biceps tendon can besurgically removed. Essentially a biceps tenodesis moves the attachmentof the biceps tendon to a position that is out of the way of theshoulder joint.

A biceps tenodesis is often, but not always, performed in patients withsignificant biceps tendon symptoms, and evidence at the time of viewingof biceps tendon inflammation or tears.

The procedure using a tissue capture anchor described herein merelyrequires drilling the bone hole and capturing the tendon with the anchorand dragging the tendon into the bone hole. In some embodiments, afurther advantage when using an awl to make the bone hole is that thewhole procedure can be percutaneous.

In one method, the procedure is performed arthroscopically. In oneembodiment, the procedure is performed non-arthroscopically. In oneembodiment, for example, a percutaneous approach may be used. In oneembodiment, a 6 mm anchor is used, although different sizes andmaterials may be used. In some instances the hole into which the tissuecapture anchor will be inserted is made by making a clearance hole forthe anchor in the superior portion of the bicipital groove 1700, asshown in FIG. 15, using a drill bit or suitably sized awl. The hole mayalso be made in any other suitable position depending on pathology ofthe tendon, etc. FIGS. 15 and 16 show different views of the bicipitalgroove and surrounding bone of the shoulder and biceps. The bicipitalgroove is a furrow on the upper part of the humerus occupied by the longhead of the biceps and is also called the intertubercular groove. Insome embodiments a 7 mm drill bit is used; however in other embodiments,a different sized drill bit can be used. In one embodiment, theclearance hole can range from 5 mm wide to 9 mm wide, from 6.5 mm to 8mm wide, or any other desired range. In other embodiments, the size ofthe clearance hole will vary, as the size depends on the size of theanchor. Depending on the softness of the bone and the size of theanchor, the hole can be from 8 mm-40 mm deep, approximately 21 mm deep,approximately 30 mm deep, or any other desired depth. For example, inone embodiment, a 6 mm tissue capture anchor is used, and for soft bone,the hole can be at least 11 mm deep. For average bone, the hole can beapproximately 10-12 mm deep. For very soft bone, the hole can beapproximately 20 mm.

The implantation site is cleared of any soft tissue in the region of thebone hole using a bur or other suitable means. Angled protrusions orteeth may be used that provide greater resistance to removal of theanchor body 110, 410 than to insertion.

In one nonlimiting embodiment, the shoulder preparation is as that usedby Richards and Brukhart (“A Biomechanical Analysis of Two BicepsTenodesis Fixation Techniques” Arthroscopy. The Journal OF Arthroscopicand Related Surgery Vol 21, No 7 (July), 2005: pp 861-866) which isincorporated by herein by reference in its entirety. The shoulder willundergo soft tissue dissection to the level of the rotator cuff. At thispoint, the supraspinatus tendon insertion is reflected by sharpdissection and the long head biceps tendon inspected for any evidence ofpathology. The tendon of the LHB is then sharply incised, freeing fromits intra-articular origin at the superior aspect of the glenoid as wellas dividing it as the musculotendinous junction so that the bicepstendon is a free segment. In other embodiments, other methods ofshoulder preparation are used.

In some exemplary embodiments, repairs are complete by drilling aclearance hole for the anchor in the superior portion of the bicipitalgroove using a standard drill bit. The tendon will then be captured bythe anchor as described above and forced in to the clearance hole andthe anchor placed to capture the tendon. The tendon will be essentiallyfolded around the anchor longitudinally, resulting in a double surfacecontact. The proximal surface of the anchor will be situated flush withthe cortical surface. In some embodiments, the hole can be located inother portions of the bone. In one exemplary embodiment, the hole may beplaced, approximately, 1 cm distal to the end of the bicipital groove.

In another embodiment, anchors as described above are used for anteriorcruciate ligament (ACL) repair. In this embodiment, a femoral tunnel isdrilled in the bone. One or two bundles of hamstring tendon are capturedby the anchor. The anchor is then inserted into the bone and deployed asdiscussed above. As described above, the tendon may be captured using avariety of methods.

In one embodiment, a hole is drilled in to the bone at a diameter ofabout 9 mm. The anchor is positioned such that a grasper tool can beimplemented to grasp a tendon. The tendon can then be manipulated andmoved or positioned. In one embodiment, a double bundle of tendons isinserted into a single bone tunnel in the femur. In one embodiment, agracilis and a semitendinosus tendon are both doubled over for insertioninto the bone hole. The anchor, which, in one embodiment may be about 8mm or 9 mm in diameter, is inserted into the bone hole with the doubledover tendons. Due to the size of the hole, the anchor, which may be 8 or9 mm in diameter is inserted with the doubled over tendons draped overits tip into the hole. The anchor is also suited for single bundlesingle tunnel and single bundle double tunnel procedures. In otherembodiments, the bone hole and the anchor can be difference sizes asneeded.

In one embodiment, the surgeon drills through the tibia and up into thefemur and loads the anchor plus tendons through the tibial tunnel. Inone embodiment, an anteromedial portal is used to drill the femoraltunnel and a separate tibial tunnel.

It will be appreciated by those of skill in the art that the tissuecapture anchor 400 and 2500 and inserter tool 1000 provide a system foreasy attachment of a tendon or tissue to bone. The anchor 400 and 2500may be inserted into bone with minimal disruption of surrounding tissue.Only an access route having the diameter of the outer tube 1200 and theanchor body 410 is required. Furthermore, the anchor can be securelyattached to the bone without having to insert additional instrumentationinto the site or without performing any cumbersome attachment maneuverssuch as knot tying.

In another embodiment, anchors as described above arc used for otherprocedures in the knee such as, for example, patellofemoral ligamentreconstruction, posterolateral corner reconstruction, and tibial anchorback-up for an ACL procedure.

In some embodiments, anchors as described above can be used for numeroustissue fixation procedures in foot and ankle. These include flexorhallucis longus transfer to Achilles for loss of Achilles mechanism;posterior tibial tendon to anterior midfoot (middle cuneiform) alsoknown as bridle/modified bridle procedure for foot drop; Lateralligament reconstruction with allograft (potentially as primary withBrostrom-Gould type procedure) for ankle instability or non-anatomiclateral ligament reconstruction using split peroneus brevis; deltoidligament reconstruction with allograft (for deltoid insufficiency);flexor digitorum longus or flexor hallucis longus transfer to peronealfor non-reconstructable peroneal tendon tears and reconstruction of torntibialis anterior with extensor hallucis longus tendon transfer.

1. A bone anchor, comprising: an expandable anchor body comprising afirst end, a second end and an axial bore; an expander positionablewithin the axial bore and comprising: a first expansion member and asecond expansion member, wherein the first expansion member has a firstexpansion portion; wherein the first expansion member is displaceablebetween a first position relative to the anchor body and a secondposition relative to the anchor body, wherein the first expansionportion is configured to expand a first end of the anchor body when thefirst expansion member is in the second position.
 2. The bone anchor ofclaim 2, wherein the second expansion member has a second expansionportion, and wherein the second expansion member is displaceable betweena third position relative to the anchor body and a fourth positionrelative to the anchor body, wherein the second expansion portion isconfigured to expand a second end of the anchor body when the secondexpansion member is in the fourth position.
 3. The bone anchor of claim2, wherein the first expansion portion has a first base portion definedby a first radius and a first shaft portion defined by a second radiusthat is smaller than the first radius.
 4. The bone anchor of claim 3,wherein the second expansion portion has a second base portion definedby a third radius and a second shaft portion defined by a fourth radiusthat is smaller than the third radius.
 5. The bone anchor of claim 4,wherein the first expansion member tapers in a first direction towardthe second expansion member, and the second expansion member tapers in asecond direction toward the first expansion member.
 6. The bone anchorof claim 1, wherein the axial bore includes a first stop configured toprevent movement of the first expansion member toward the first end. 7.The bone anchor of claim 1, wherein the axial bore includes a secondstop configured to prevent movement of the second expansion membertoward the second end.
 8. The bone anchor of claim 1, wherein each ofthe first end of the anchor body and the second end of the anchor bodyis expandable by pivoting from a position between the first end and thesecond end.